Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000026820
Ethics application status
Approved
Date submitted
5/01/2012
Date registered
6/01/2012
Date last updated
4/08/2023
Date data sharing statement initially provided
12/03/2019
Date results provided
12/03/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The CAP Study: Evaluating a comprehensive universal and targeted intervention designed to prevent substance use and related harms in Australian adolescents
Scientific title
The CAP intervention: A comprehensive universal and targeted intervention to prevent substance use and related harms in Australian adolescents aged 13 to 15
Secondary ID [1] 279668 0
APP1004744, APP1124958.
Universal Trial Number (UTN)
U1111-1121-8314
Trial acronym
CAP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Substance use prevention 285486 0
Prevention of substance use-related harms 285487 0
Condition category
Condition code
Mental Health 285671 285671 0 0
Addiction
Public Health 285672 285672 0 0
Other public health

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participating secondary schools will be randomly allocated to one of four groups. One group will serve as the control group and receive their usual drug education in school while the remaining three groups will receive either of the following interventions: Arm 1- Climate Schools Intervention (CL): The Climate Schools program aims to reduce the use of Australia’s most commonly used licit and illicit drugs: alcohol and cannabis, and related harms. The Program consists of twelve 40-minute lessons delivered as part of the Year 8 PDHPE syllabus. The lessons are delivered weekly for 6 weeks (Climate Schools Alcohol module) and then approximately a 6 month break before the delivery of another 6 weekly lessons (Climate Schools Alcohol and Cannabis module). The first part of each lesson is completed individually over the internet where students are engaged through cartoon storylines which impart information about the short- and long-term effects of alcohol and cannabis, normative alcohol and cannabis use, refusal skills, and first aid. The second part of each lesson is a group or class activity delivered by the teacher which reinforces the information in the cartoons and allows interactive communication between students. Teachers are provided with a manual containing the activities, implementation guidelines, links to the education syllabus and summaries for each lesson. The first six lessons focus specifically on alcohol and are delivered approximately six months prior to the remaining six lessons which focus on cannabis. The overall duration of Arm 1 is approximately 6 months. Arm 2- Preventure Intervention (PR): The Preventure program is a brief personality-targeted substance use preventive intervention for high-risk adolescents aged 13-15 years. Unlike universal programs, this selected personality-targeted approach addresses personality risk-factors for early-onset substance misuse and other risky behaviours. Participating students will be screened at baseline using the 24-item Substance Use Risk Profile (SURPS) questionnaire which assesses variation in personality risk for substance abuse along four dimensions: Sensation Seeking, Impulsivity, Anxiety Sensitivity and Hopelessness (Woicik et al., 2009). The Preventure program is also consistent with new models which conceptualise substance use as being driven by personality traits such as impulsivity and disinhibition (Dick et al., 2008). This program involves two 90-minute group sessions (6-8 students per group) delivered one week apart by a trained clinical psychologist and co-facilitator. The interventions are conducted using manuals which incorporate psycho-educational and cognitive behavioural components, and include real life scenarios shared by high-risk youth in specifically-organised focus groups. In the first session, participants are guided in a goal setting exercise, designed to enhance motivation to change behaviour. Psycho-educational strategies are used to teach participants about their target personality variable and associated problematic coping behaviours like avoidance, interpersonal dependence, aggression, risky behaviours and substance misuse. They are then introduced to the cognitive behavioural model and guided in breaking down personal experience according to the physical, cognitive and behavioural components of an emotional response. A novel component to this intervention approach is the fact that all exercises discuss thoughts, emotions and behaviours in a personality-specific way, e.g. identifying situational triggers and cognitive distortions related to Sensation Seeking specifically. In the second session, participants are encouraged to identify and challenge personality-specific cognitive distortions that lead to problematic behaviours. The overall duration of Arm 2 is approximately 3 months. Arm 3- Climate Schools and Preventure Intervention (CAP): The CAP intervention will deliver the Climate Schools and Preventure programs, described above, simultaneously with the aim of providing a comprehensive ‘universal’ and ‘targeted’ model to prevent substance use and related harms in Australian adolescents. The overall duration of Arm 3 is approximately 9 months.

CAP LONG TERM FOLLOW UP 2017-2019
Results at 3 years have shown the effectiveness of universal and selective approaches in preventing harmful alcohol use among low- and high-risk adolescents. The CAP long-term follow up is an opportunistic extension of the landmark CAP study, whereby follow up of this cohort will extend beyond the completion of secondary school and into the critical transition period of early adulthood. The investigators will extend longitudinal follow-up for a further 3 years, inviting the participants to take part in an two additional online surveys assessing demographic information, drinking and drug use habits, and behavioural and personality inventories
Intervention code [1] 283953 0
Prevention
Intervention code [2] 283954 0
Lifestyle
Intervention code [3] 283955 0
Behaviour
Comparator / control treatment
The combined Climate Schools and Preventure (CAP) Intervention will be compared to:

a) A "standard treatment" control group - Students will not receive the Climate Schools or the Preventure Interventions. Participants will complete their standard Year 8 PDHPE classes, delivered by their teacher

b) Climate Schools only intervention - Students will receive 12 x 40minute lessons delivered as part of the Year 8 PDHPE syllabus. Each lesson consists of computer lessons and activities from the program manual, to be administered by the teacher

c) Preventure only intervention - Students will attend their standard PDHPE lessons, delivered by their teacher. Students who are identified as being 'high-risk' based on their personality profile will be invited to participate in 2 x 90minute sessions carried out by a registered Clinical Psychologist and co-facilitator. These sessions incorporate psycho-educational and cognitive behavioural components.
Control group
Active

Outcomes
Primary outcome [1] 286215 0
Uptake and harmful use of alcohol and illicit substance
Timepoint [1] 286215 0
Assessed at baseline and at 6, 12, 24 and 36 months after intervention commencement. Uptake and harmful use will be assessed by an adapted version of the School Health Alcohol Harm Reduction Project (SHAHRP) Patterns of Alcohol and Cannabis Use instrument, the Diagnostic Interview Schedule for Children (DISC-IV), the Alcohol and Lifestyle Questionnaire and nine items relating to student's current and intended future use of alcohol and illicit drugs.
Also, 5 questions will be included to assess student's intention to use alcohol and other drugs in the future.

Long-term follow-up:
Primary outcomes will be assessed long-term via the administration of 2 additional follow-up surveys spanning 5, 6 and 7 years post intervention.
Primary outcome 1: Drinking frequency and binge drinking will be assessed using an adapted version of the Patterns of Alcohol Index.
Primary outcome [2] 286216 0
Substance use related harms
Timepoint [2] 286216 0
Assessed at baseline and at 6, 12, 24 and 36 months after intervention commencement. Harms caused by cannabis will be assessed using 12 items adapted from the SHAHRP survey instrument and a set of questions adapted from the Adolescent Cannabis Problems Questionnaire. Harms caused by alcohol will be assessed using an abbreviated version of the Rutgers Alcohol Problem Index.

Long-term follow-up:
Primary outcomes will be assessed long-term via the administration of 2 additional follow-up surveys spanning 5, 6 and 7 years post intervention.
Primary outcome 2: Alcohol related harms will be measured using an abbreviated version of the Rutgers Alcohol Problem Index,
Primary outcome [3] 286217 0
Alcohol and cannabis knowledge and attitudes
Timepoint [3] 286217 0
Assessed at baseline and at 6, 12, 24 and 36 months after intervention commencement, assessed by questions adapted from the SHAHRP questionnaire, and the Cannabis Quiz.

Long-term follow-up:
Primary outcomes will be assessed long-term via the administration of 2 additional follow-up surveys spanning 5, 6 and 7 years post intervention.
Primary outcome 3: Probable diagnosis of alcohol use disorder will be measured using a self-report symptom checklist based on DSM-5 criteria.
Secondary outcome [1] 295397 0
Mental health comorbidity
Timepoint [1] 295397 0
Assessed at baseline and at 6, 12, 24 and 36 months after intervention commencement. Psychological distress will be assessed using the Kessler 6 Scale, depression and anxiety symptoms will be assessed using the Brief Symptom Inventory (BSI) and Psychotic symptoms will be measured using the Thoughts and Feelings Questionnaire
Secondary outcome [2] 344608 0
Behavioural problems
Timepoint [2] 344608 0
Assessed at baseline and at 6, 12, 24 and 36 months after intervention commencement. Behavioural problems will be assessed by The Strengths and Difficulties Questionnaire, the Reactive Proactive Aggression Questionnaire, and the Self-Regulatory Efficacy Scale.
Secondary outcome [3] 344609 0
Other drug use
Timepoint [3] 344609 0
Assessed at baseline and at 6, 12, 24 and 36 months after intervention commencement. Other drug use will be measured based on questions from the National Drug Strategy Household Survey 2010.
Secondary outcome [4] 344610 0
Use of illicit drugs.
Timepoint [4] 344610 0
Secondary outcomes will be assessed long-term via the administration of 2 additional follow-up surveys spanning 5, 6 and 7 years post intervention. Cannabis use will be assessed using cannabis questions from the National Drug Strategy Household Survey 2013, Cannabis-related harms will be assessed using a 6-item scale asking participants whether they experienced any of 6 different harms related to their cannabis use, Probable diagnosis of cannabis use disorder will be assessed using a self-report symptom checklist, and the use of ecstasy and methamphetamines will be measured using two items that ask whether participants have used ecstasy/MDMA or methamphetamines respectively in the past 6 months, and how many times they have used these substances.
Secondary outcome [5] 344611 0
Assess efficacy of intervention in reducing aggression.
Timepoint [5] 344611 0
Secondary outcomes will be assessed long-term via the administration of 2 additional follow-up surveys spanning 5, 6 and 7 years post intervention. Reactive proactive aggression will be measured using the Reactive-Proactive Aggression Questionnaire, and self-report violent behaviours will be measured using an adapted version of the Self-Reported Delinquency Scale.
To corroborate self-report measures and to further examine the criminal involvement of this group as well as hypothesised intervention effects on drug-related violent offending, consent will be sought to match participant data with court record data from the Bureau of Crime Statistics and Research (BOSCAR).
Secondary outcome [6] 344612 0
Peer problems
Timepoint [6] 344612 0
Assessed at baseline and at 6, 12, 24 and 36 months after intervention commencement. Peer problems will be assessed by the Bullying Questionnaire and the Personal Experience Checklist

Eligibility
Key inclusion criteria
Baseline: All students (male and female) between the ages of 12 and 15 yrs.

Long-term follow-up: Those that participated at baseline will be eligible to continue with the study, via the administration of 2 additional follow-up surveys spanning 5, 6 and 7 years post intervention.
Minimum age
12 Years
Maximum age
15 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Baseline study: Those younger than 12 or older than 15 years of age.

Long-term follow-up: Those who did not participate in the baseline survey are not eligible to take part in the 2 long-term follow-up surveys spanning 5, 6, and 7 years post intervention.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Schools will be randomised to one of the four study groups using the online program Research Randomizer. Allocation will be concealed via central randomisation using computer software.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Schools will be randomised to one of the four study groups using the online program Research Randomizer (simple randomisation using computer software).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Factorial
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
16/09/2011
Actual
1/02/2012
Date of last participant enrolment
Anticipated
Actual
30/09/2012
Date of last data collection
Anticipated
31/10/2019
Actual
23/09/2019
Sample size
Target
1920
Accrual to date
Final
2190
Recruitment in Australia
Recruitment state(s)
NSW,VIC

Funding & Sponsors
Funding source category [1] 284449 0
Government body
Name [1] 284449 0
National Health and Medical Research Council
Country [1] 284449 0
Australia
Primary sponsor type
Individual
Name
Prof Maree Teesson
Address
The Matilda Centre for Research in Mental Health and Substance Use
Level 6, Jane Foss Russell Building (G02)
The University of Sydney
Darlington NSW 2006
Country
Australia
Secondary sponsor category [1] 283377 0
University
Name [1] 283377 0
University of Sydney
Address [1] 283377 0
Level 6, Jane Foss Russell Building (G02)
The University of Sydney
Darlington NSW 2006
Country [1] 283377 0
Australia
Other collaborator category [1] 260423 0
University
Name [1] 260423 0
Kings College
Address [1] 260423 0
Addictions Department
Institute of Psychiatry
Kings College London WC2R 2LS
Country [1] 260423 0
United Kingdom

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286429 0
UNSW Human Research Ethics Committee
Ethics committee address [1] 286429 0
Ethics committee country [1] 286429 0
Australia
Date submitted for ethics approval [1] 286429 0
Approval date [1] 286429 0
29/08/2011
Ethics approval number [1] 286429 0
HREC 11274 and HREC 16881

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33584 0
Prof Prof Maree Teesson
Address 33584 0
National Drug and Alcohol Research Centre University of NSW Sydney NSW 2052
Country 33584 0
Australia
Phone 33584 0
+612 9385 0333
Fax 33584 0
+612 9385 0222
Email 33584 0
[email protected]
Contact person for public queries
Name 16831 0
Dr Nicola Newton
Address 16831 0
National Drug and Alcohol Research Centre
University of NSW
Sydney NSW 2052
Country 16831 0
Australia
Phone 16831 0
+612 9385 0204
Fax 16831 0
+612 9385 0222
Email 16831 0
[email protected]
Contact person for scientific queries
Name 7759 0
Prof Maree Teesson
Address 7759 0
National Drug and Alcohol Research Centre
University of NSW
Sydney NSW 2052
Country 7759 0
Australia
Phone 7759 0
+612 9385 0333
Fax 7759 0
+612 9385 0222
Email 7759 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified individual participant survey data from all assessment waves (baseline, 6-, 12-, 15-, 18-, 24-, 30-, 60- and 72- month follow-ups)
When will data be available (start and end dates)?
Waves 1-9: available from 1st July 2022 until 1st July 2042
Available to whom?
Data are potentially available to researchers from not-for-profile organizations, commercial organisations/other and based in any location.
All data requests will be considered by the primary sponsor on a case-by-case basis. Requests must include a methodologically sound proposal. Specific conditions of use may apply and will be specified in a data sharing agreement (or similar) that the requester must agree to before access is granted.
The statistical analysis code (syntax) and data collected for the study, including de-identified participant data, will be made available to researchers on request to the corresponding author and with appropriate reason when accompanied by study protocol and analysis plan.
Data will be shared after the approval of a proposal by a committee of the current research team with a signed data access agreement. Informed consent forms are available in the published protocol.
For further information, see our data sharing policy (https://www.sydney.edu.au/policies/showdoc.aspx?recnum=PDOC2014/366&RendNum=0).
Available for what types of analyses?
Any type of analysis (IPD meta-analysis, systematic review, and other research questions) assessed on a case-by-case basis.
How or where can data be obtained?
As of 1st July 2022, access can be requested via this google form. Data request will be reviewed on a case by case basis
For further information, see our data sharing policy - (https://www.sydney.edu.au/policies/showdoc.aspx?recnum=PDOC2014/366&RendNum=0).


What supporting documents are/will be available?




Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseA cross-validation trial of an Internet-based prevention program for alcohol and cannabis: Preliminary results from a cluster randomised controlled trial.2016https://dx.doi.org/10.1177/0004867415577435
EmbaseThe validity of the Substance Use Risk Profile Scale (SURPS) among Australian adolescents.2016https://dx.doi.org/10.1016/j.addbeh.2015.09.015
EmbasePathways to prevention: protocol for the CAP (Climate and Preventure) study to evaluate the long-term effectiveness of school-based universal, selective and combined alcohol misuse prevention into early adulthood.2018https://dx.doi.org/10.1186/s12889-018-5554-y
EmbaseA Novel Approach to Tackling Bullying in Schools: Personality-Targeted Intervention for Adolescent Victims and Bullies in Australia.2020https://dx.doi.org/10.1016/j.jaac.2019.04.010
EmbaseEvaluating the differential effectiveness of social influence and personality-targeted alcohol prevention on mental health outcomes among high-risk youth: A novel cluster randomised controlled factorial design trial.2020https://dx.doi.org/10.1177/0004867419877948
EmbaseIs Adolescent Alcohol Use Linked to Spikes in Aggressive Behaviour? A Growth Curve Analysis.2021https://dx.doi.org/10.1007/s11121-020-01188-2
EmbaseThe 7-Year Effectiveness of School-Based Alcohol Use Prevention From Adolescence to Early Adulthood: A Randomized Controlled Trial of Universal, Selective, and Combined Interventions.2022https://dx.doi.org/10.1016/j.jaac.2021.10.023
N.B. These documents automatically identified may not have been verified by the study sponsor.